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Use of Conjugated Linoleic Acid as a Nutraceutical for Weight Loss in Humans (CLA)

Primary Purpose

Body Weight, Body Composition, Hyperlipidemia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Clarinol G-80 ® treatment

Safflower oil

G-c9, t11

About this trial

This is an interventional basic science trial for Body Weight focused on measuring Conjugated linoleic acid, Body weight, Body composition, Blood lipid profile, Body inflammatory and oxidative status

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Study subjects will be defined as overweight or obese, hyperlipidemic males, with a LDL-C level of greater than 2.5 mmol/L.Subjects will be between 18-60 years old and must have a body mass index (BMI) of 25-36 kg/m2. Subjects with thyroid diseases will be included in the study as long as they have been shown to be stable in response to their medications and thyroid therapy will have to be maintained at a stable dose throughout the study.

Exclusion Criteria:

subjects taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors, high dose dietary supplements or fish oil capsules (> 4 g/day), guggul, lecithin, evening primrose oil within the last six months. In addition subjects will no be allowed to consume any of these medications during the study;
subjects who have taken plant sterol supplements within the past six weeks and consume plant sterol supplements during the trial;
subjects who currently have diabetes, kidney, heart or liver disease or have had any of these diseases at any time during the past 3 months. In addition any development of diabetes mellitus, kidney, heart or liver disease during the trial will lead to exclusion from the trial;
subjects who smoke or consume large amounts of alcohol (> 2 drinks/day);
subjects who have any major food allergies or are vegetarian;
subjects that use natural or pharmaceutical weight loss supplements or products known to affect lipid metabolism at the beginning and end of each treatment period as well as the washout periods;
subjects who are sensitive to the Asteraceae/Compositae family (e, g., ragweed, marigolds, daisies).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Safflower oil

Clarinol G-80®

G-c9, t11

Arm Description

This arm of the study constitutes the control phase

Outcomes

Primary Outcome Measures

Changes in body weight, body fat mass, and lean body mass

Secondary Outcome Measures

Changes in inflammation and oxidation markers

Full Information

NCT ID

NCT01047280

First Posted

January 8, 2010

Last Updated

January 11, 2010

Sponsor

University of Manitoba

1. Study Identification

Unique Protocol Identification Number

NCT01047280

Brief Title

Use of Conjugated Linoleic Acid as a Nutraceutical for Weight Loss in Humans

Acronym

CLA

Official Title

Use of Conjugated Linoleic Acid as a Nutraceutical for Weight Loss in Humans

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Manitoba

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to examine how a naturally occurring fat found in meats, such as beef and lamb and milk, called conjugated linoleic acid (CLA), will affect your body weight and body fat content, blood fat levels, as well as selected safety parameters. The CLA will be supplemented in an oil form and will be added to solid foods as provided by the metabolic kitchen at the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN).

Detailed Description

In order to investigate the effectiveness of CLA on body weight and composition, as well as blood lipids, a double-blinded, 3-phase crossover trial will be conducted in moderately overweight (BMI=25-40 kg/m2), borderline hypercholesterolemic (LDL-C ≥ 2.5 mmol/L) men between the ages of 18-60 years. During three 8-week phases separated by 4-week washout periods, and under supervision to ensure compliance, 28 subjects will consume in random order (i) Control: 3.5 g/d of safflower oil, (ii) Clarinol G-80®: 3.5 g/d of 50:50 mixture of t10, c12 and c9, t11 CLA and (iii) c9, t11: 3.5 g/day of c9, t11 CLA. Body weight, fat mass and lean body mass will be measured at beginning and end of each phase by dual energy X-ray absorptiometry (DEXA). Baseline and endpoint blood samples will collected to determine blood lipid profile, and different safety parameters, including insulin sensitivity (HOMA-IR index), and concentrations of inflammatory (hs-CRP, TNF-α, IL-6) and oxidative (Oxidized-LDL) biomarkers. Effect of CLA consumption on fatty acid oxidation will also be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Body Weight, Body Composition, Hyperlipidemia, Inflammation, Oxidative Stress

Keywords

Conjugated linoleic acid, Body weight, Body composition, Blood lipid profile, Body inflammatory and oxidative status

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Safflower oil

Arm Type

Placebo Comparator

Arm Description

This arm of the study constitutes the control phase

Arm Title

Clarinol G-80®

Arm Type

Experimental

Arm Title

G-c9, t11

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Clarinol G-80 ® treatment

Intervention Description

dietary supplement of 3.5g/day 50-50 mixture of t10, c12 and c9, t11 CLA. In addition, the amount of mixed natural tocopherols is 5mg/g (0.05%).

Intervention Type

Dietary Supplement

Intervention Name(s)

Safflower oil

Intervention Description

3.5 g/d of safflower oil

Intervention Type

Dietary Supplement

Intervention Name(s)

G-c9, t11

Intervention Description

3.5 g/day of c9, t11 CLA

Primary Outcome Measure Information:

Title

Changes in body weight, body fat mass, and lean body mass

Time Frame

At baseline and endpoint of each phase

Secondary Outcome Measure Information:

Title

Changes in inflammation and oxidation markers

Time Frame

At baseline and endpoint of each phase

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Study subjects will be defined as overweight or obese, hyperlipidemic males, with a LDL-C level of greater than 2.5 mmol/L.Subjects will be between 18-60 years old and must have a body mass index (BMI) of 25-36 kg/m2. Subjects with thyroid diseases will be included in the study as long as they have been shown to be stable in response to their medications and thyroid therapy will have to be maintained at a stable dose throughout the study. Exclusion Criteria: subjects taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors, high dose dietary supplements or fish oil capsules (> 4 g/day), guggul, lecithin, evening primrose oil within the last six months. In addition subjects will no be allowed to consume any of these medications during the study; subjects who have taken plant sterol supplements within the past six weeks and consume plant sterol supplements during the trial; subjects who currently have diabetes, kidney, heart or liver disease or have had any of these diseases at any time during the past 3 months. In addition any development of diabetes mellitus, kidney, heart or liver disease during the trial will lead to exclusion from the trial; subjects who smoke or consume large amounts of alcohol (> 2 drinks/day); subjects who have any major food allergies or are vegetarian; subjects that use natural or pharmaceutical weight loss supplements or products known to affect lipid metabolism at the beginning and end of each treatment period as well as the washout periods; subjects who are sensitive to the Asteraceae/Compositae family (e, g., ragweed, marigolds, daisies).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter JH Jones, Ph.D.

Organizational Affiliation

University of Manitoba

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

21593349

Citation

Joseph SV, Jacques H, Plourde M, Mitchell PL, McLeod RS, Jones PJ. Conjugated linoleic acid supplementation for 8 weeks does not affect body composition, lipid profile, or safety biomarkers in overweight, hyperlipidemic men. J Nutr. 2011 Jul;141(7):1286-91. doi: 10.3945/jn.110.135087. Epub 2011 May 18.

Results Reference

derived

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Use of Conjugated Linoleic Acid as a Nutraceutical for Weight Loss in Humans

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